Clinical comparison of two 8.5% amino acid injection products.
A comparative clinical trial of Travasol 8.5% without electrolytes and FreAmine II 8.5% was performed. Thirty-six patients were admitted to the double-blind study and assigned randomly to receive either Travasol (16 patients) or FreAmine II (20 patients). All patients had abnormal renal and liver function. Nitrogen balance was compared, and metabolic complications were monitored by evaluating BUN, serum creatinine, creatinine clearance, serum CO2, SGOT, SGPT, serum LDH, and serum alkaline phosphatase. There were no significant differences found in nitrogen balance of patients receiving either Travasol or FreAmine (p greater than 0.05). The Bun for days 1--5 in the Travasol group was significantly greater (p = 0.02), but the difference (3 mg/dl) was not considered clinically significant. All other comparative measurements of renal function, liver function, and acid-base balance remained the same throughout the study period (p greater than 0.05). Based on these results, the use of either FreAmine II or Travasol can promote positive nitrogen balance in a TPN patient population with normal renal and hepatic function with no difference in metabolic complications.
D000328:Adult; D000368:Aged; D000596:Amino Acids / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009584:Nitrogen / Q000378:metabolism; D010288:Parenteral Nutrition; D010289:Parenteral Nutrition, Total; D011897:Random Allocation
D000596:Amino Acids; D004338:Drug Combinations; D009584:Nitrogen